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Abstract:

A method, system and device for addressing the reduction of snoring
includes a removable or dissolvable strip of material that adhere to
mucosal tissue of a person's soft palate to provide stiffening support
therefore, thus reducing the occurrence of vibration of such tissue
during sleep. Preferred embodiments include of a specially textured
surface, either one both or at least the outer side of an adhesive strip
(the side facing away from the mucosal tissue to which it is attached)
that has anti-microbial characteristics, bioluminescent expressions, etc.
and a surface topography that resists bioadhesion of undesired bacteria
that are typically present in a human's mouth.

Claims:

1. A non-surgical method for treating snoring in a subject, the method
comprising: orally administering to a subject in need thereof a mucosal
adhesively attachable film for use in the reduction of symptomatic,
habitual or social snoring caused by a flutter of tissue in the soft
palate, wherein said film stiffens the soft palate tissue to reduce the
flutter that causes snoring and/or palatal obstruction of the upper
airway.

2. A buccal bioadhesive strip having no active drugs, that when applied
to the tissue of the soft palate, stiffens the tissue to reduce
vibration, comprising: at least one coating layer having a surface
topography for resisting bioadhesion, said at least one layer comprising
a polymer, said coating layer having a pattern defined by a plurality of
spaced apart features attached to or projected into a base surface, said
plurality of features each having at least one microscale dimension and
having at least one neighboring feature having a substantially different
geometry, wherein an average spacing between adjacent ones of said
features is between 0.5 and 5 μm in at least a portion of said coating
layer, said coating layer resisting bioadhesion as compared to said base
surface.

3. A buccal bioadhesive strip comprising a strip having a first and
second side, the first side having a bioadhesive that binds to a mucosal
membrane for at least 3 hours while inside a person's mouth, the second
side having a specially textured surface that has anti-microbial
characteristic derived from its surface topography, said topography such
that it resists bioadhesion of undesired bacteria that are typically
present in a human's mouth.

4. The strip of claim 3, wherein said geometry limits the gag reflexes of
a person while still achieving the objective of reducing the vibrational
flutter of tissue that causes snoring.

5. The strip of claim 3 wherein said strip extends over a majority of the
soft palate region and over at least 50% of the persons' hard palate.

6. The strip of claim 3 wherein said strip includes a toxic substance
associated with the surface of the strip effective to kill undesired
bacteria in the mouth.

7. The strip of claim 3 wherein said strip comprises bioluminescent
material to facilitate a user's ability to view when viewing in a mirror,
the correct placement of the strips in one's throat, said bioluminescent
material comprising one of luciferin, luciferase and aequorin.

9. The strip of claim 3 wherein said strip is devoid of paper, rice or
hemp products. The strip of claim 3 wherein said strip has compounds
residing thereon to facilitate the growth of desired bacteria, such as
those deemed beneficial to a person's health, said bacteria permitted to
grow on said strip while in a person's mouth to further promote the
reduction of vibration of underlying tissue.

10. The strip of claim 3 wherein said strip includes phase change
materials that when certain temperatures are encountered while in use, a
phase change occurs, resulting in physical characteristics of the overall
strip to be modified so as to increase the stiffness of the strip,
reducing vibration of the underlying tissue.

11. The strip of claim 3 wherein said strip comprises materials that
cause the strip to stiffen when exposed to one of: 1) vibration of
underlying tissue during the snoring of an individual; and 2) slight
changes in temperature.

12. The strip of claim 3 wherein said strip comprises structural features
that direct airflow in a manner that further reduces the occasion of
throat tissue vibration, such features selected from the group consisting
of grooves, hollow structures and curved, elevated surfaces. The buccal
bioadhesive strip of claim 2, wherein said strip is adapted to adhere to
the soft palate region of a person and includes at least one polymer
selected from the group consisting of pullulan, hydroxypropylmethyl
cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl
pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate,
polyethylene glycol, tragacanth gum, guar gum, acacia gum, arabic gum,
polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl polymer,
amylose, high amylose starch, hydroxypropylated high amylose starch,
dextrin, pectin, chitin, chitosan, levan, elsinan, collagen, gelatin,
zein, gluten, soy protein isolate, whey protein isolate, casein and
mixtures thereof, said film having a thickness that provides sufficient
structural integrity and stiffness to the soft palate of a person to
reduce vibrational movement of the person's soft palate tissue to such an
extent that snoring noises are reduced, said film having a size and shape
to accommodate covering at least half of the soft palate of the person,
said strip having a multifingered shape that leaves uncovered at least
50% of the soft palate region of a user.

13. The film as set forth in claim 4, wherein the film has first and
second sides and the first side has adhesive material associated
therewith and the second side does not.

14. The film as set forth in claim 5, wherein the second side has a
lubricant associated therewith.

15. The strip of claim 3 wherein the strip has an overall geometry
particularly suited for the individual's mouth, said strip having at
least one perforated tear line to facilitate smaller sizes to be
fashioned.

Description:

RELATED APPLICATIONS

[0001] This application claims priority from U.S. Provisional Patent
Application Ser. No. 61,439,652 filed on Feb. 4, 2011 and U.S.
Provisional Patent Application Ser. No. 61/556,023 filed Nov. 4, 2011.
The entire disclosure of the prior applications is considered to be part
of the disclosure of the accompanying application and is hereby
incorporated by reference

FIELD OF THE INVENTION

[0002] The present invention is directed to a method, system and device
for addressing the reduction of snoring and in particular, is directed to
the use of dissolvable strips of material that adhere to mucosal tissue
of a person's soft palate to provide stiffening support therefore, thus
reducing the occurrence of vibration of such tissue during sleep.

BACKGROUND OF THE INVENTION

[0003] Snoring is a problem suffered by a large number of people. Snoring,
upper airway resistance syndrome and obstructive sleep apnea syndrome
(OSAS) are all breathing disorders related to narrowing of the upper
airway during sleep. Individuals over age 65 experience such sleep
difficulties, and the prevalence of sleep problems will therefore
increase as the over-65 population increases. Each year, sleep disorders,
sleep deprivation, and excessive daytime sleepiness add billions of
dollars annually to the cost of health care and in lost productivity.
When the muscles at the base of the tongue and the uvula (the small
fleshy tissue hanging from the center of the back of the throat) relax
and sag, the relaxed tissues may vibrate as air flows past the tissues
during breathing, resulting in snoring. Snoring affects about half of men
and 25 percent of women--most of whom are age 50 or older.

[0004] Snoring is a common chronic medical problem that is associated with
episodic partial upper airway obstruction during sleep. Snoring afflicts
millions of people worldwide. Snoring can lead to chronic fatigue that
follows sleep deprivation and is considered by many to be a serious
medical problem. The sound of snoring is produced by turbulent air-flow
moving through an area of partial upper airway obstruction that produces
resonant vibrations in the soft tissues adjacent to the upper airway. In
many cases, snoring is caused by the relaxation of the tongue and the
resulting blockage of the breathing airway. When the tongue of the
sleeping individual relaxes and creates such a blockage and the
individual subsequently forcibly passes air through the breathing airway,
loud vibrations between the tongue and surrounding tissues will often
result in the noises commonly referred to as snoring. Snoring is created
by the vibration of the pharyngeal soft tissues as air passes through an
airway that is too small to allow for smooth, unimpeded flow.

[0005] A percentage of those who snore also suffer from sleep apnea. The
most common type of sleep apnea, obstructive sleep apnea (OSA), is caused
by repeated collapse of soft tissues forming the walls of the upper
airway in the sub-glottal region during sleep. Currently accepted
treatment for OSA typically includes continuous positive airway pressure
(CPAP). CPAP, as currently practiced, involves connection of a
pressurized air delivering device to the mouth or nose of the patient.
This device typically is connected to a pressurized air source in the
form of a compressor or tank with a regulator. These pressurized air
supplies are expensive, large, and noisy. Because body position and sleep
stages vary throughout the night, the CPAP mask pressure often does not
remain constant. To address this problem, many sleep clinicians select a
sufficiently high pressure setting to ensure that respiratory
disturbances are reliably inhibited even in the least favorable
situations. Unfortunately, this necessitates a needlessly high mask
pressure for periods during which it is not required. Furthermore, the
high mask pressure may make CPAP uncomfortable. Variable patient
compliance remains a significant problem. Studies have found that up to
25% of patients discontinue CPAP therapy.

[0006] Airway dryness may also contribute to CPAP discomfort. The high
flow rates used during CPAP may overwhelm the capacity of the nasal
mucosa to heat and humidity inspired air. Compounding this problem is a
phenomenon known as mouth leak. Mouth leak occurs during approximately
one-third of total sleep time in people who suffer from dryness of the
nose and throat. It results from the mouth being partially or fully open
during nasal CPAP therapy. During mouth leak, a portion of air bypasses
the nasal membranes and exits via the mouth. Normally, expiratory air
releases heat and water back into the nasal mucosa by condensing on the
cooled mucosal surface. Leaked air is not conditioned in this way, and
results in intensification of the excessive dryness experienced during
the use of CPAP. To compensate for the decreased heat and humidification
caused by moth leak, blood vessels in the nose dilate; however, their
capacity to do so may be overwhelmed by the high flow rates produced by
CPAP. As the patient continues to mouth leak, further moisture is lost
and blood vessels continue to dilate, thereby narrowing the airway. The
net result of this process is increased nasal resistance and nasal
congestion.

[0007] It is known that such snoring can be alleviated by displacing the
individual's lower jaw into a position that is relatively forward of its
normal position. A variety of known devices are designed to forwardly
displace an individual's lower jaw while they are sleeping to thereby
alleviate snoring. Brace-like bite splints of this type for preventing
snoring serve to move the mandibula slightly forwards, since in this
position of the mandibula the respiratory tracts are opened wider,
enabling a person to breathe more freely without snoring. Some appliances
hold the lower jaw forward during sleep while others affect tongue
position. Oral appliances relieve OSAS and snoring by realigning the jaw
and/or tongue in relation to the head. Oral appliance therapy, while
increasingly popular to treat selected cases of sleep disordered
breathing, is not completely effective in all situations.

[0008] Oral appliances can be categorized generally into three types based
on design. The first type mechanically lifts the soft palate. The
effectiveness of this appliance type is presumed to be due to a
prevention of collapse at the velopharyngeal level. The second type
positions the tongue anteriorly while the mandible retains its customary
relation to the maxilla. Some oral appliances of this type use a suction
cup; others are designed to work through nocturnal neuromuscular
training. Most oral appliances are of the third type-mandibular
advancement appliances--which, as the name implies, advance the mandible.
Because the mandible is the attachment for the genioglossus and other
tongue muscles, the tongue moves anteriorly, as it does with the second
type. The mechanism of action of the second and third of these oral
appliance designs is to enlarge the hypopharyngeal airway by moving the
base of the tongue farther from contact with the posterior wall of the
pharynx, thereby reducing the likelihood of collapse from inspiration.

[0009] Nasal sprays mainly work as a snoring remedy for those who suffer
from nasal blockage. Snoring caused by problems with the uvula or soft
palate (as most snoring problems are) are not resolved by the use of,
nasal sprays or nasal passage opening devices.

[0010] U.S. Pat. No. 5,465,734 to Snorex, Inc discloses a tongue retaining
device formed of a flexible polyvinyl material and hollow interior that
fits over the tongue and requires a specialist to take upper and lower
jaw impressions of the patient to produce a tailored device for the
patient.

[0011] Numerous attempts have been made towards treating OSA and snoring.
These include placing implants in either the tissue of the soft palate or
the pharyngeal airway as disclosed in U.S. Pat. No. 6,250,307 to Conrad
et al. and U.S. Pat. No. 6,431,174 to Knudson et al. After implantation,
tissue grows into the attachment ends and a bioresorbable member resorbs
after tissue in-growth, causing tissue contraction, which results in a
debulking of the tissue and movement of tissue away from opposing tissue
surfaces in the pharyngeal upper airway.

[0012] Physicians often treat minor snoring by recommending that patients
take simple measures such as increasing exercise, losing weight,
decreasing alcohol consumption, reducing smoking, altering sleeping
position, and using dental or nasal appliances. Although these relatively
simple measures can be somewhat effective, many patients do not
experience satisfactory relief from snoring. As a result, for many
patients the only alternative is surgery.

[0013] One of the earliest surgical procedures developed, which is still
in use today, is uvulopalatopharygoplasty. In addition to the poor
success rates of this expensive procedure, various complications were
common, including serious postoperative bleeding, pain, velopharyngeal
incompetence, palatal dryness, nasopharyngeal stenosis, long-term voice
changes and partial loss of taste.

[0014] Other palatal stiffening procedures, called radio frequency
ablation (RFA), have been employed with mixed results, where radio
frequency energy is delivered to the soft palate to cause scarring of the
palatal muscle. Unfortunately, RFA must be performed multiple times to
obtain satisfactory results.

[0015] In U.S. Pat. No. 5,988,171 to Sohn et al., suture material is
placed around a base of the tongue and secured to the jaw, thereby moving
the tissue of the base of the tongue away from the opposing tissue of the
pharyngeal airway. This procedure, referred to as tongue suspension, is
uncomfortable. Another technique described in U.S. Pat. No. 5,843,021 to
Edwards et al., includes applying radio frequency ablation to either the
tongue base or of the soft palate to debulk the tissue of the tongue or
palate, respectively.

[0016] Other snoring remedies involve the injecting of a microparticle
solution into a patient's soft palate to stiffen the soft palate, thereby
stiffening the soft palate with the injected composition to reduce
palatal flutter.

[0017] Unfortunately, all current treatments produce results that are far
from optimal. Surgery and re-positioning devices are effective in only a
minority of OSA patients and many people are subjected to painful and
expensive procedures without benefit. While CPAP is effective in many
situations, the treatment is uncomfortable and not well tolerated during
long-term use. A substantial number of patients given CPAP discontinue
therapy within the first year after initiation. Surgical procedures to
remedy snoring are expensive, painful, and of dubious long-term benefit.

[0018] There is a long-felt but unsolved need for a simple, effective,
inexpensive non-surgical method and device for treating snoring,
especially one that does not rely upon uncomfortable mouth or tongue
repositioners or the use of continuous positive airway pressure machines.

[0019] To date, nonsurgical approaches to the management of OSAS include
behavioral modification, drug therapy, continuous positive airway
pressure (CPAP), and use of mechanical devices. Behavioral modifications
include avoidance of alcohol and sedative medications, alteration of
sleep position, avoidance of sleep deprivation, and weight loss.

SUMMARY OF THE INVENTION

[0020] The present invention is directed to an improved method, system and
product to provide desired palatal stiffening to achieve a reduction of
snoring by reducing or substantially eliminating palatal flutter. In
various embodiments, the present invention achieves desired stiffening of
the soft palate to reduce palatal flutter through the use of mucosal
strips that are positioned in a person's mouth before sleep. Unlike the
prior art methods and devices that require permanent tissue changes, such
as implantation of material, such as pillar system tubes,
micro-particles, or the creation of scar tissue so as to affect the
physical characteristics of the soft palate, the present invention is
used only during times when snoring is an issue--e.g. mainly at night.
Thus, during hours when a person is awake, there are no adverse tissue
changes to the soft palate that would cause pain, affect breathing or
talking or swallowing, which are issues that the prior art systems and
methods present. Nor does the present method and system involve the
embarrassing and uncomfortable use of jaw or tongue adjustment devices
that are both uncomfortable and awkward in situations where a person is
in bed with another person, such as a spouse who is also attempting to
sleep. Instead, the use of the mucosal strip as set forth herein provides
a relatively discrete way in which a person can avoid snoring by
stiffening the soft palate tissue for a predetermined time period that is
limited in duration, such that in many cases, the strip is dissolved by
morning. Moreover, the person with a snoring problem can self adjust the
amount of strips employed to address the vagrities of a particular
person's soft palate area, need for stiffness, particular placement for
comfort and effectiveness, etc. Unlike other devices that are a
"one-size-fits-all" proposition, the ability to use more than one strip;
to overlap strips, to reinsert strips during the night if snoring issues
appear, etc. is made possible to adjust for particular situations and to
address the severity of a particular person's snoring at any given
particular moment.

[0021] Another aspect of the present invention includes the ability to
load or impregnate the mucosal strips with any number of active agents to
achieve other desirable aspects, such as breath freshening;
administration of particular vitamins, medicinal components, salving of
mouth sores, short or long term medication through buccal and mucosal
tissues, etc.

[0022] The particular dimensions, thickness, size, area surface texture,
flexibility, adhesive characteristics, flavoring and taste, composition
(e.g. in terms of medicine, vitamins, nutraceuticals, etc.) for a
particular strip can be adjusted as one of skill in the art will
appreciate. In one embodiment, and unlike most presently available breath
strips (e.g. such as Listerine breath strips) the strips employed in the
present invention are both thicker, so as to provide more structural
integrity to soft palate tissues upon which such strips adhere, and also
have more long term (from at least about 5 minutes to several hours),
preferably for at least about 3 hours, more preferably at least about 5
hours and most preferably at least about 6 or more hours--roughly
equating to the period of time of a person's sleep and/or length of
snoring experience. Moreover, in preferred embodiments the mucosal strips
are designed to adhere well with each other when placed on palate tissue
so that layering of the strips can be accomplished so as to custom build
a desired thickness of the strips over tissue to be covered. This permits
a user to layer as many strips as deemed necessary to stiffen the soft
palate tissue in a manner that is personally comfortable for such user
while also being sufficient to address the particular snoring issue
experienced by such user. The area of tissue to be covered can be
addressed by either having the person provide strips side-by-side to
cover the area; by having certain tissue areas provided with thicker
ultimate strip depth than other areas (e.g. providing for the option of
stiffening certain palate soft tissue more than directly adjacent
tissue), and even providing strips having different characteristics in
terms of a variety of factors, such as taste, composition, adherence or
dissolvability characteristics, area, shape, thickness, flavor, duration
of flexibility characteristics, etc. In some embodiments, films of
desired thickness and having desired properties in terms of dissolving
rate, flexibility, provision of stiffness over time, adhesion duration,
ability to cause reversible contraction of soft palate tissue (e.g. to
thus enhance the desired stiffening of targeted tissue that would
otherwise vibrate during snoring), can be fashioned, by cutting, forming
in a particular mold, etc. to cover a desired soft palate area. For
example, the particular physical area of an individual's soft palate will
vary in size, dimensions, degree of soft tissue available for undesired
vibration during a snoring episode, etc. and so cutting films, strips,
areas of pre-manufactured material to cover such areas is made possible
by the present invention. In other words, while in some embodiments
standard sized strips of material may be available such that a person can
layer, place side-by-side, orient distinctly, etc. strips of
appropriately selected strips, on other embodiments, custom strips or
films having particular shapes, such as one that covers the particular
area of that particular person's soft palate tissue region, is
contemplated. As disclosed herein below, strips are referred
alternatively to oral films, mucosal films, etc.

[0023] Oral films having desired duration of adhesion and freedom from an
adverse feeling in the oral cavity on use are selected that adhere to the
particular regions of a person's soft palate, thereby stiffening the
region and reducing or eliminating snoring.

[0024] Preferably, a hydrophilic pressure-adhesive hydrogel is employed
that has desirable characteristics. In one embodiment, a hydrophobic
pressure-sensitive adhesive or bioadhesives is used to provide desired
control of tack, adhesive and water sorption properties required for
optimal application mucosal tissue. U.S. Pat. No. 5,166,233 to Kuroya, et
al. is incorporated herein by this reference for suitable adhesives in
this regard. U.S. Pat. No. 6,552,024 to Choi is likewise incorporated
herein in its entirety by this reference, as is U.S. Pat. No. 7,906,140
to Bromley, et al.; U.S. Pat. No. 6,803,420 to Cleary et al.; U.S. Pat.
No. 7,984,714 to Hausmann et al.; U.S. Pat. No. 7,276,246 to Zhang; U.S.
Pat. No. 5,578,315 to Chien et al.; U.S. Pat. No. 7,470,397 to Meathrel
et al. U.S. Pat. Publication No. 20110033542 to Myers, et al.; U.S. Pat.
No. 7,138,135 to Chen; U.S. Pat. No. 7,441,559 to Nelson.

[0025] Suitable oral films may be formulated using polymers, plasticizers,
flavors, colors and sweeteners. The oral films are manufactured using
solvent casting method, rolling method, extrusion method and solid
dispersion method. Oral films are preferably selected that are not fast
dissolving film and that will therefore remain in the oral cavity for a
longer time and retained at the site of application. Oral film strips
have hit the mainstream in the last few years as a new way of freshening
the breath.

[0026] Polymers: The polymer may be water soluble, water insoluble, or a
combination of one or more either water soluble or water insoluble
polymers. The polymer may include cellulose or a cellulose derivative.
Specific examples of useful water soluble polymers include, but are not
limited to, pullulan, hydroxypropylmethyl cellulose, hydroxyethyl
cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl
cellulose, polyvinyl alcohol, sodium aginate, polyethylene glycol,
xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum,
polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers,
starch, and combinations thereof.

[0031] One (or a combination) of the following processes may be used to
manufacture the oral films: solvent casting; Hot-melt extrusion; Solid
dispersion extrusion; and Rolling.

[0032] Solvent Casting: The oral film is preferably formulated using the
solvent-casting method, whereby the water-soluble ingredients are
dissolved to form a clear viscous solution. Entrapped air is removed by
vacuum. The resulting solution is cast as a film and allowed to dry,
which is then cut into pieces of the desired size. Water-soluble
hydrocolloids used to prepare films include: hydroxypropylmethyl
cellulose (HPMC), hydroxypropyl cellulose (HPC), pullulan, sodium
alginate, pectin and carboxymethyl cellulose (CMC).

[0033] Hot melt extrusion (HME) is used to prepare granules,
sustained-release tablets, transdermal and transmucosal drug delivery
systems. Processing films by this technique, involves shaping a polymer
into a film via the heating process rather than through the traditional
solvent casting method.

[0034] Solid dispersion extrusion: The term "solid dispersions" refers to
the dispersion of one or more active ingredients in an inert carrier in a
solid state in the presence of amorphous hydrophilic polymers and also
using methods such as melt extrusion.

[0035] Rolling method involves preparation of a film by preparation of a
pre-mix, addition of an active and subsequent formation of a film. For
example, a master batch which includes the film-forming polymer, polar
solvent, and any other additives is added to the master batch feed tank
and is controllably fed via a first metering pump and control valve to
either or both of the first and second mixers. After blending for a
sufficient time to provide a uniform matrix, a specific amount of the
uniform matrix is then fed to the pan through the second metering pumps.
The metering roller determines the thickness of the film and applies it
to the application roller. The film is finally formed on the substrate
and carried away via the support roller. The wet film is then dried using
controlled bottom drying, desirably in the absence of external air
currents or heat on the top (exposed) surface of the film. A
disintegration test may be employed to determine the time at which a film
breaks when brought into contact with water or saliva. The disintegration
time is the time when a film starts to break or disintegrate. Thickness
and mass play a role in determining the dissolvable film's physical
properties. The "tensile strength" (psi) is the property of film that
requires a load to cause load deformation failure of film. Tensile
strength was evaluated according to ASTM International Test Method for
Thin Plastic Sheeting (D 882-02). An electronic dynamometer AG/MC1
(Acquati, I) may be used and tensile strength and elongation may be
calculated to arrive at a suitable strop for the intended uses and
applications as set forth herein. Tensile strength (N/mm2)=Breaking
force (N)/Cross-sectional area of sample (mm2). Percent elongation
is measured when the film snaps as sufficient force applied so as to
exceed the elastic limit. Elongation at break (%)=Increase in length at
breaking point (mm)/Original length (mm)×100%. Thickness tests may
be carried out using an electronic micrometer MI-1000 (Cheminstruments,
USA). The thickness of the film sample may be measured using a micrometer
(Digimatic Micrometer, Mitutoyo, Tokyo, Japan) at five locations (center
and four corners), and the mean thickness calculated. Folding endurance
is determined by repeatedly folding a small strip of film at the same
place till it breaks. Film flexibility may be determined by adapting the
ASTM bend mandrel test (D 4338-97) and a film may be bent over a mandrel
and examined for cracks over the area of the bend in a strong light.

[0036] Taste masking for oral film systems can be employed so that any
offensive bitter or poor taste of is addressed. One method of
taste-masking is encapsulation by a polymeric covering sufficient to mask
the taste of the film. Orally disintegrating thin films based on a
water-soluble polymer are selected so that the film does not disintegrate
rapidly within seconds after contact with water or saliva, but rather, is
retained on the mucosal membrane for a significant period of time,
preferably several hours, so that the film remains in place during the
sleep of the person employing the same Films prepared using chitin or
chitosan are suitable as an oral mucoadhesive and water-resisting
adhesive.

[0037] A suitable oral mucosa adhesive includes one that is at least
moderately water-soluble, pliant polymer artificial dentifrice (AD) film
that may be prepared from a hydroxypropyl cellulose-M (HPC-M) ethanol and
polyethylene glycol. When applied to the wet surface of the mucosa, films
of the present invention preferably show excellent adhesion and are able
to cover oral mucosa long enough to last for a substantial period of time
while the person is asleep. Such films provide mechanical stabilization
of the tissue of the pharyngeal wall.

[0038] FIG. 1 shows, in cross-section, a naso-pharyngeal area of an
untreated patient. FIG. 1 shows the nose N, mouth M and throat TH. The
tongue T is shown in an oral cavity OC of the mouth. A hard palate HP
(containing a bone B) separates the oral cavity OC from the nasal cavity
NC. The nasal concha C (soft tissue which defines, in part, the nasal
sinus--not shown) resides in the nasal cavity NC.

[0039] The soft palate SP (a muscle activated soft tissue not supported by
bone) depends in cantilevered manner at a leading end LE from the hard
palate HP and terminates at a trailing end TE. Below the soft palate SP,
the pharyngeal wall PW defines the throat passage TP. A nasal passage NP
connects the nasal cavity NC to the pharyngeal wall PW. Below an
epiglottis EP, the throat passage TP divides into a trachea TR for
passing air to the lungs and an esophagus ES for passing food and drink
to the stomach.

[0040] The soft palate SP is operated by muscles (not separately shown and
labeled) to lift the soft palate SP to urge the trailing edge TE against
the rear area of the pharyngeal wall PW. This seals the nasal cavity NC
from the oral cavity OC during swallowing. The epiglottis EP closes the
trachea TR during swallowing and drinking and opens for breathing.

[0041] For purposes of this disclosure, the nasal cavity NC, oral cavity
OC and throat passage TP are collectively referred to as the
naso-pharyngeal area of the patient (defining, in part, the pharyngeal
airway PA in FIGS. 5 and 13) with the area including the various body
surfaces which cooperate to define the nasal cavity NC, oral cavity OC
and throat passage TP. These body surfaces include outer surfaces of the
nasal concha C, the upper and lower surfaces of the soft palate SP and
outer surfaces of the pharyngeal wall PW. Outer surfaces means surfaces
exposed to air. Both the upper and lower surfaces of the soft palate SP
are outer surfaces. Snoring can result from vibration of any one of a
number of surfaces or structures of the naso-pharyngeal area. Most
commonly, snoring is attributable to vibration of the soft palate SP.
However, vibratory action of the nasal concha C and the pharyngeal wall
PW can also contribute to snoring sounds. It is not uncommon for
vibratory action from more than one region of the naso-pharyngeal area to
contribute to snoring sounds. Sleep apnea can result from partial or full
collapse of the naso-pharyngeal wall during sleep.

[0042] Incorporated in its entirety by this reference is patent
publication No. 20070218114 to Duggan. In various embodiments, the
present invention includes a soluble composition for the administration
of an active ingredient to a site on the mucus membranes of the throat of
a human or animal subject.

[0043] In certain embodiments, a base material of a material having
predetermined dissolving characteristics, formed as an inter-oral film
(similar in various respect to available breath freshening strips) is
selected to act as a stiffening substrate for a person's soft palate
tissue. As the base material dissolves, under action of moisture in the
mouth or on open skin or wound, the ability to retain desired tension of
the underlying tissue is maintained for a period of time sufficient to
reduce the incidence of snoring. In some embodiments, a controlled
quantity of an active ingredient is released and is delivered to the soft
tissue at the back of the throat it is able to have the desired effects.
Such active ingredients may include those believed to also address
snoring of an individual, and thus, the strips of the present invention
also act (in addition to the structural support for damping or reducing
undesired vibration of soft palate tissue) as delivery devices for such
anti-snoring (or other medicinal purpose) materials, substances and
compounds.

[0044] Reference herein to a strip is to any soluble prolonged release
presentation of the composition which is conformable and is adapted to
lie in a subject's mouth without causing obstruction or interfering with
breathing, talking or swallowing or the like, or to conform to the
surface of a subjects open skin or wound. Preferably the strip comprises
a flexible film or the like. In use, the strip to be placed in a
subject's mouth is intended to be placed at the back of the throat, near
to the desired area of operation. Preferably the strip (or strips,
whether layered, certain portions more dissolvable than others, etc.) are
positioned on a person's soft palate. This can be achieved via a person's
fingers or through the use of an applicator (otherwise described and
illustrated.) The strip is particularly suited to delivery of ingredients
having activity in relation to snoring or apnea, by delivery to the
mucosa of the throat, in particular at the soft tissue in the pharyngeal
region of the back of the throat, to keep the pharyngeal membranes moist
and lubricated. The strip is conformed as a relatively thin planar
structure to facilitate desired rates of inter-oral dissolution. For
example, in certain embodiments, a single strip may be preferably no more
than about 150 micron thick, more preferably in the range 100-400 micron
thick, and in other embodiments may be over 500 microns in thickness. In
other embodiments, however, the ability to layer strips on top of one
another provides for the manufacture and availability of strips of more
traditional thickness, such as those for example of the breath strips of
Listerine, etc. The strip may be of any suitable shape, for example being
square or rectangular for ease of storage, placement, distribution in
packages, but is preferably generally planar and approximately 0.5 to 2
cm in length and breadth. Again, the particular shape and dimensions of a
strip can be varied as required to address individual snoring issues, the
degree of tissue stiffness of the soft palate required to address a
particular snoring issue, etc. Thus one aspect of the present invention
is that a person may modify the number, placement, kind, type, shape,
time of application, frequency of application, etc. to address particular
situations, which may vary over time and under any given set of
circumstances. No prior art method or device employed in the battle
against snoring offers such a variety and flexibility of treatment
options as do the various embodiments of the present invention.

[0045] In certain embodiments, the strip is manufactured from a material
which is soluble within the subject's mouth under the action of saliva
and oral enzymes, o under the action of tissue fluids. In other
embodiments, however, the strip is made so as not to dissolve and thus,
is repeatedly applied to a person's soft palate at bedtime to alleviate
snoring. A reusable device that adds the requisite structure to the
particular soft palate tissue can have appropriate adhesive integral or
added as needed to remain in a desired position. The customization of
such a strip in terms of shape, size, characteristics regarding flavor,
thickness, adhesive qualities etc. are within the present scope of the
invention.

[0046] In certain embodiments, the base material for the strip is any
suitable soluble solid material, which term includes gel-like and other
materials which are sufficiently solid to enable the strip to be
conformed to its desired shape. In particular, a carrier or base material
of the strip may comprises a soluble gel material, and is for example
based upon on an organic gel, which could for example be a fish, animal,
bovine or marine gelatin or vegetal gelatin-like product, a
polysaccharide, a cellulosic material, pectin such as from fruits, or
other suitable base. Other materials may be added to the base gel, for
example to stabilize, add other effects flavor etc. The carrier or
soluble base material may be inert, or may itself have an activity or
other desired property, whether in relation to the primary purpose of the
invention or otherwise.

[0047] The no-snore strip of the present invention may further include one
or more compositions, or alternatively, may solely be provided with
materials meant and intended solely to provide desired structural support
to reduce vibrational movement of soft palate tissues. Active agents may
be used either impregnated in the strip material, added later (e.g.
anti-snoring agents can be sprayed on such strips), layered in a fashion
so that an adhesive strip is separate from an active layer strip; the
provision of strips that can encompass or otherwise carry one or more
active ingredient strips, liquids, etc. in a pouch (not shown) such that
administration of various active ingredients can be achieved via
attachment of an active ingredient container to the soft palate adhesive
strip. Time release and slow release aspects of delivery can be achieved
via suitable selection of permeable barriers employed to contain active
ingredients and then the association of such barriers to soft palate
adhesive strips. The layering of strip for separate and distinct purposes
of structural tissue support versus for administering active ingredients
is a entire segment of different embodiments of the present invention.

[0048] Components that can be included in strips or associated with strips
in the various ways described herein include agents that may include
additional active ingredients, including a plurality of active
ingredients having an activity in relation to a particular condition or
the throat or throat disorder, oral conditions, or conditions of snoring
and/or sleep apnoea, open skin or wound healing or repair agents and/or
active ingredients having other desired activity.

[0049] Preferably in certain embodiments, active ingredients include at
least one active ingredient with physical (moisturizing, lubricating,
cooling etc) or pharmacological (for example decongestant,
anti-histamine, anti-bacterial, anti-inflammatory, analgesic etc)
activity. For example active ingredients might include ingredients having
any desired physical or pharmacological activity on the mucous membranes
of the throat, including without limitation decongestants, lubricants,
antibacterial and antiseptic compositions, anti-histamines,
anti-inflammatory compositions, analgesics, and other medicaments and
non-medicaments. Additional ingredients may include breath-fresheners and
deodorizers. Inactive ingredients may be added in suspension or solution
for example to stabilize or preserve the soluble base, balance the pH of
the base, bring the base to closer approximation to isotonic
concentration etc. The composition may additionally include adjuvants and
the like such as vitamins for example selected from Ascorbic acid
(vitamin C) which enhance the active ingredient effect. The composition
may include additional ingredients for formulation purposes, for example
selected from sodium chloride which maintains favorable isotonicity.

[0050] In still other embodiments, the use of additional ingredients may
provide for chemical binding, and for example for the use of liposome
technology, can be employed. In some embodiments of the invention a part
or all of the active ingredients are encapsulated within encapsulation
structures selected to provide the desired degree of adhesion to the
mucous membranes of the throat, and adapted to release the active
ingredients slowly over time in situ. These encapsulation structures may
be distributed within the base material in the strip composition. In one
embodiment, the encapsulation structures comprise multilamellar
microparticles. The multilamellar microparticles are selected to exhibit
good adhesion to the mucous membranes of the throat, and are small enough
to be effectively distributed in the strip. The multiple layers may be
structured to give slow release of the active ingredient over the desired
time period, so that a single strip dose gives sustained activity over
time, for example providing for measurable activity for a sustained
period of four or more hours, and ideally of for example 6 to 12 hours,
to give overnight effectiveness.

[0051] Microparticles are preferably sized and shaped to form an effective
distribution within the base material in the strip as a composition in
accordance with the invention. The microparticles in particular comprise
generally spherical particles or microspheres. Particle sizes in the
range 0.1 to 50 μm, and for example 1 to 20 μm are likely to be
preferred. Particle levels of 5-25% within the composition are preferred
but depend on the particular tissue characteristics being addressed. For
example, tissue stiffening materials can be employed that dissolve at
different rates and that affect the amount and number of strips that may
be required to address snoring issues over time. Microparticles may be
are adapted to facilitate slow release of the active ingredients over
time, and are preferably inherently able to show good adhesion to the
mucous membranes of the throat. Active ingredients are thus stabilized in
situ on the mucous membranes at the back of the throat, and then released
steadily at the site where they are required.

[0052] Using the present invention, it becomes possible to maintain
reasonable levels of activity over the sort of time scale necessary to be
effective overnight, and for example to assist in providing a relatively
less disturbed night's sleep. Microparticles comprise multiple layered
structures formulated with one or more of: surfactant layers (comprising
any type of surfactant such as anionic, non-anionic, cationic,
phospholipids and the like such as sucroesters and guar
hydroxypropyltrimonium chloride), and hydrophobic or lipophilic materials
such as aliphatic and aromatic hydrocarbons, optionally halogenated,
higher alcohols, ketones and the like, for example including Vitamins (A,
E, D), carotenoides, polyphenols, vegetable oils, essential oils,
phytosterols, lipophilic preservatives, menthol, linalool, eucalyptol,
and the like; and polar layers including solvents or polar media such as
water, glycerol, PEG, sorbitol, glycol, hydrophilic materials such as
alcohols or ethoxylated alcohols, carboxylic acids or salt of a fatty
acid, quaternary ammonium derivatives, sulphonates or sulphates and the
like, vitamins (B, C), flavonoides, 18-beta glycyrrhetinic acid and
derivatives, glycerol, active ingredients such as plant extract as
hereinbefore defined; hydrophilic preservative; cellulose polymer,
hyaluronic acid and derivatives, alpha-hydroxide acid, and the like. Also
possible inclusion are pectin; cellulose; sodium hyaluronate; guar
hydroxypropyltrimonium chloride; polysorbate 60, and optionally
additionally cellulose; xanthan gum; chitosan or quaternary ammonium. In
one embodiment, such strip composition comprises: solvent 30-60%,
Humectant 8-14%, Texturant 0-2%, Preservative 0-2%, and a Acidity
regulator 0-1% (all by weight). Microparticles thus preferably comprise
multi-lamellar structures of surfactant layers, which are able to
encapsulate active ingredients to a very high degree for protection and
controlled release--whether that be rapid release (e.g. for certain
tissue stiffening components) or longer term release, such as breath
freshing components). The strips are formulated to be adapted to enhance
adhesion to human skin, and hence to fix the particles in position on the
mucous membranes of the throat. Suitable compositions include 30 to 50%
surfactant, 30 to 50% polar medium, and 10 to 60% active binding agent,
comprising hydrophilic and hydrophobic agents as appropriate.

[0053] Microparticles providing the controlled binding for slow release of
physically active ingredients at the active site on the mucous membrane
of the throat of the human, non-human mammal or other animal subject to
provide an active effect, bind effectively to the membranes to stiffen
the tissue and thus reduce or eliminate undesired snoring. Microparticles
are advantageous to fix the active ingredients adsorbed within each
shaped layer in position on the mucous membranes of the user, protect the
active ingredients and slowly release them in situ, and might also assist
in providing a desired lubricating effect. Active or inactive ingredients
might be provided either encapsulated within the microparticles or
separately in suspension or solution within the base for various
purposes.

[0054] Formulation of oral drug strips involves the application of both
aesthetic and performance characteristics such as strip-forming polymers,
plasticizers, active pharmaceutical ingredient, sweetening agents, saliva
stimulating agent, flavoring agents, coloring agents, stabilizing and
thickening agents. From the regulatory perspectives, all excipients used
in the formulation of oral drug strips should be approved for use in oral
pharmaceutical dosage forms. For example, films that incorporate a
pharmaceutically active ingredient are disclosed in expired U.S. Pat. No.
4,136,145 to Fuchs, et al. These films may be formed into a sheet, dried
and then cut into individual doses. The Fuchs disclosure alleges the
fabrication of a uniform film, which includes the combination of
water-soluble polymers, surfactants, flavors, sweeteners, plasticizers
and drugs. These allegedly flexible films are disclosed as being useful
for oral, topical or enteral use. Examples of specific uses disclosed by
Fuchs include application of the films to mucosal membrane areas of the
body, including the mouth, rectal, vaginal, nasal and ear areas.

[0055] With respect to manufacturing of strips, one of skill in the art
will appreciate the various methods and components involved to achieve
desired qualitative and quantitative aspects. For example, if a
dissolvable strip is intended to last over a several hour period, the
changes in content of materials used in the manufacture, for example, of
breath strips, can be adjusted to lengthen the time it takes to dissolve
such strip. Flavor, binding and adhesion abilities, etc. are adjusted
suitably to achieve desired results. Thus, while the present
specification provides some detail as to how to make and use certain
embodiments of the present invention, reliance on incorporation by
reference is appropriate to encompass the myriad of ways in which a
particular product is produced. All of such techniques, however, are well
within the skill of one of ordinary skill in the art in view of the
guidance and direction provided herein.

[0056] Thin films are typically made using wet casting manufacturing
process and may be, for example, up to a maximum of 10 mils thick, as
above such thickness it being commonly understood that matrix like
products become "sheets" when they exceed a thickness of 10 mils. Wet
cast film manufacture and products are described in U.S. Pat. Nos.
7,425,292 and 5,948,430, also incorporated herein in its entirety by this
reference. Films may initially have a thickness of about 500 μm to
about 1,500 μm, or about 20 mils to about 60 mils, and when dried have
a thickness from about 3 μm to about 250 μm, or about 0.1 mils to
about 10 mils Desirably, the dried films will have a thickness of about 2
mils to about 8 mils, and more desirably, from about 3 mils to about 6
mils. The thickness of films may exceed 2.7 mils despite some adverse
mouth feel.

[0058] Preferably the strips of the present invention are made in a manner
that do not dissolve in fewer than ten seconds, thus distinguishing the
same from common breath strips widely available. The strops of the
present invention may have a weight of from 30 to several hundred mg.,
preferably over 33 mg. Preferably, strops of the present invention have
sufficiently high moisture content to impart the product with flexibility
and to avoid becoming brittle, e.g. the strips should preferably avoid
cracking when bent.

[0059] In certain embodiments, the methods employed by MonoSol Rx with
respect to a thin film drug delivery technology can be used, preferably
providing a strop having a relatively thin film, which is similar in
size, shape and thickness to a postage stamp. Preferably, the strips of
the present invention, when containing active ingredients, have the
ability to carry doses of prescription products up to 80 mg or exceeding
1000 mg, and even more preferably, over 200 mg. Suitable taste masking
agents can be employed depending upon the active ingredients involved.

[0060] Other embodiments of the present invention are directed to multiple
film laminates that can have distinct adherence and qualitative features
and components associated with separate layers, thus facilitating
differences in manufacture, activity, structural characteristics, such as
flexibility, dissolution rate, etc. The strips of the present invention
provide the requisite pliability and tensile strength necessary to
securely adhere to a person's mucosal tissues for at least one hour, more
preferably at least two hours, and even preferably a bioadhesive polymer
is selected from the group consisting of polycarbophil, carbomer, one or
more acrylic polymers, one or more polyacrylic acids, copolymers of these
polymers, a water soluble salt of a co-polymer of methyl vinyl ether and
maleic acid or anhydride, a combination thereof and their salts.

[0061] In other embodiments, to achieve the desired thickness of strips
for structural support purposes of the present invention, a so-called
slab or sheet manufacturing technique is employed that uses a nonaqueous,
extrudable composition comprising at least one thermoplastic polymer in
an amount of more than 20 wt % of the whole composition, such composition
comprising at least one thermoplastic polymer and one or more bioactive
ingredients in a form that may be placed on the mucosa and having an
average dissolution time of preferably more than 50 minutes, more
preferably at least about 2 hours, and even more preferably at least
about 5 hours. In some embodiments the strip is in a sheet and has a
surface area of approximately 0.25-1.5 in. and a thickness of
approximately 10-70 mil.

[0062] A strip may be impregnated or coated with a dose of active
ingredient and other components. Strips may be coated with other
components as desired. Suitably strips are made up in bulk films which
are subsequently cut to size and shape as hereinbefore defined.

[0063] For purposes of written description and enablement of the various
embodiments of the present invention, the following published
applications and issued patents are incorporated herein by this reference
in their entireties: U.S. Pat. Nos. 7,067,116 and 7,648,712 to Bess, et
al.; U.S. Pat. No. 7,632,525 to Dodds, et al.; U.S. Pat. No. 6,502,574 to
Stevens, et al.; 20050159637 to Nelson et al.; U.S. Pat. No. 7,845,356 to
Paraschac et al.; U.S. Pat. No. 7,824,588 to Yang et al.; 20090098192 to
Fuisz; U.S. Pat. No. 7,500,484 to Nelson; Fentanyl compound-containing
edible patch to be applied to oral mucosa, to Furusawa et al.; U.S. Pat.
No. 7,566,310 to Badr et al.; U.S. Pat. No. 5,190,053 to Meer et al.;
Schmidt U.S. Pat. Nos. 6,748,951 and 6,467,485.

[0064] In still other embodiments, to avoid fears that adhesion will not
suffice to attach a trop to a person's soft palate tissue, strips can
also be afforded an attachment line, such as dental floss, so that the
strip can be also anchored to one's teeth, tooth or around the tongue to
ensure that the strip does not present a choking hazard if detached. Thus
in one embodiment, a loop or segment of dental floss anchored to teeth or
around gum line or a tongue can prevent swallowing of the strip if it
become detached.

[0065] Preferably, strips of the present invention comprise a mixture of
at least three types of film forming agents, such as maltodextrins,
fillers (for example, microcrystalline cellulose (MCC)) and hydrocolloids
(for example, sodium aliginate), suitably adapted to adhere to oral
surfaces of an oral cavity, and in particular the soft palate. While
structural support for the soft palate is the principal direction of the
present invention, as this reduces or eliminates snoring, other
embodiments also comprise the use of such strips to deliver or release
oral care agent(s). Such agents include anti-microbial agents and
salivary stimulants to treat, for example, halitosis, dental plaque,
gingivitis, xerostomia, dry mouth, like oral conditions or combinations
thereof. Further, the oral care edible film can act as a breath freshener
effective against malodor. In other embodiments, both a longer acting (if
not entirely non-dissolvable strip) can be employed in association with
one or more other strips having other desired characteristics. For
example, a structural support strip can be used to reduce snoring while
an additional strip can be associated with such structural strip to
achieve breath freshening, delivery of a medicinal compound, etc.--with
such second strip having entirely distinct dissolution characteristics.

[0066] The oral cleansing and breath freshening effects of the edible film
of the present invention can be achieved by entrapping the oral care
agents within the oral cavity to provide extended efficacy. In this
regard, the highly dissolvable edible film can act as a medium through
which a pharmaceutically active oral agent can be administered via a
mucous membrane of the oral cavity.

[0067] Strips may further include a variety of other suitable ingredients,
such as softeners, colorants, flavoring agents, emulsifiers, surface
active agents, thickening agents, binding agents, sweeteners, fragrances,
other like ingredients or combinations thereof.

[0068] The strips may comprise a hydrocolloid of any suitable type, amount
and number of hydrocolloids. In an embodiment, the hydrocolloid can
constitute between about 10% to about 50% by dry weight of the edible
film, preferably about 20% to about 30% by dry weight. The hydrocolloid
can be derived from, for example, natural seaweeds, natural seed gum,
natural plant exudates, natural fiber extracts, biosynthetic gums,
gelatins, biosynthetic process starch or cellulosic materials, alginates,
sodium alginate, calcium alginate, carrageenans, guar gum, locust gum,
tara gum, gum arabic, ghatti gum, agar gum, xanthan gum, pectin, other
like hydrocolloid source material or combinations thereof.

[0069] The present invention also relates to a method for placing the
anti-snore strip on the soft palate, as by an applicator having a handle
and an extension that attaches reversibly to a strip and that can be
positioned to deliver the strip to the soft palate without causing a gag
reflex from the user.

[0070] In certain embodiments of the present invention, the size and
number of adhesive strips contacting the soft palate of a person can be
varied. For example, while a larger size strip (e.g. an expanse of
material that covers a particular area of soft palate tissue) can be
greater than the dimensional area of a person's soft palate, thereby
extending beyond the perimeter of the soft palate, it can also be of a
smaller area and may extend therefore over only some, e.g. a central
portion; half of the area of the soft palate--leaving the other side of
the soft palate area uncovered by any strip, etc. Moreover, more than one
strip can be employed to attach to the soft palate region, such as by
providing two separate smaller strips on the soft palate with some space
between, more preferably at least three or more individual strips within
the soft palate region. The general objective of placing one or more
strips in or about the soft palate region is intended to provide required
structural support for the tissue in a manner that reduces the instances
of vibration of such tissues in a way that results in snoring. So in
certain embodiments, strips of various desired shapes and sizes can be
employed to populate the area of one's soft palate to dampen vibrational
movement caused by the passage of air through the region when asleep. In
some individuals, the surface area of adhesive strips will be relatively
minor as compared to others, who may require substantially all of the
soft palate tissue area to be covered to achieve the objective of reduced
snoring. Due to the possible discomfort caused by any adhesive strip
being positioned for a lengthy period of time on one's throat, the goal
would be to present a minimum area of strip that also accomplishes the
desired reduction or elimination of snoring. Moreover, with the slight
risk that a larger strip may become detached and cause undesired blockage
of air flow, possible choking, etc. there is a desire to reduce the
amount of material being positioned in one's throat to address snoring
problems. By administering the minimum number of strips, using strips of
the smallest dimensions in terms of thickness, projection from the tissue
into the airflow path, etc. such concerns are addressed. Thus, in one
embodiment, the application of dots of adhesive strip material may be
sufficient to address snoring issues, with such dots being of such a
small size that both airflow restriction and choking concerns are not
significant. The use of such smaller sized strips also eliminate the need
for some type of anchoring device or member, such as may be useful when
larger strips are employed. In such larger area strip uses, dental
floss-type anchors can be secured to the strip (where dental floss loops
or extensions can be securely connected with or integral with such
strips) and the other end of such dental floss can be secured to some
other feature to prevent unintended swallowing or inhalation of the strip
if the strip were to become loose from the soft palate tissue. Layering
or over-lapping of smaller strips may also be useful to address such
airflow and/or choking concerns while still addressing the overall
objective of reducing vibrations of the tissue, e.g. stiffening the soft
palate in a fashion that reduces the occurrence of snoring.

[0071] In still other embodiments, other structural members can be
associated with the adhesive strips.

[0072] In still other embodiments of the invention, wafer-type structures
can be employed to address the stiffening of soft palate tissue. These
wafers, preferably having one side sticky so that it adheres well for a
predetermined amount of time to a person's mucosal membrane, but with the
other side not sticky, and more preferably lubricated (e.g. thorough the
use of lubricants that are imbedded in the strips, such as via
microencapsulated lubricants, etc.) to facilitate both comfort to the
user, avoidance of undesired adherence of soft palate to other tissues,
etc.

[0073] Incorporated herein by this reference is 20110009834 to Asmussen
with respect to various particular components that can be utilized to
form strips. The strip-shaped forms can comprise a flexible material
suitable for pharmaceutical and/or cosmetic use by humans and/or in
animals, i.e. materials that do not have any unwanted side effects.
Unwanted side effects would be toxic effects, the causing of irritations
or the triggering of allergic reactions, for example. Suitable materials
may be, for example, thermoplastic polymers, thermoset polymers,
copolymer films, paper, waxes, textiles (nonwovens, knitted fabrics and
woven fabrics), chalks, films, gels and wood composites, as well as
combinations of the aforementioned materials. Specific polymers suitable
as material for the strips may be selected from the group of polymers
consisting of cellulose ethers, methyl acrylates, hydroxyalkyl celluloses
such as hydroxypropyl methyl cellulose, hydroxypropyl cellulose,
hydroxyethyl cellulose, methyl cellulose and carboxymethyl cellulose,
polysulfones, polyvinyl pyrrolidones, crosslinked polyvinyl pyrrolidones,
polyvinyl pyrrolidone-vinyl acetate copolymers, polyvinyl alcohols,
polyacrylic acids, polyacrylate polymers, crosslinked polyacrylic acids,
polyethylene oxides, polyethylene glycols, polyvinyl alkyl ether-maleic
acid imide copolymers and carboxyvinyl polymers. Suitable polymers may
also be selected from the group of polymers consisting of marine
colloids, natural gums and polysaccharides. These polymers include, for
example, sodium alginate, carrageenan, xanthan gum, gum acacia, gum
arabic, guar gum, pullulan, agar, chitin, chitosan, pectin, karaya gum,
zein, hordein, gliadin, carob meal, tragacanth and other polysaccharides,
starches such as maltodextrins, amylose, amylopectin, maize starch,
potato starch, rice starch, tapioca starch, pea starch, sweet potato
starch, barley starch, wheat starch, waxy maize starch, modified starch,
dextrins, levan, elsinan and gluten; and proteins such as collagen, whey
protein, casein, milk protein, soya protein, gelatine, waxes and
colophony, as well as synthetic waxes and bees wax. By combining two or
more of the aforementioned polymers, the properties of the strip of
material, such as mucoadhesiveness, flexibility, solubility behaviour,
swelling behaviour and the like, can be adapted according to one's wishes
and requirements. The strip of material, or the layers of the strip of
material, comprise/comprises at least one polymer, which represents an
essential component of the strip of material or of the layer(s). The
polymer portion amounts to at least 5%-wt. and preferably not more than
90%-wt., preferably 10 to 70%-wt., more preferably 30 to 60%-wt., in each
case relative to the strip of material or the layer, respectively. The
strip of material, or individual layers of the strip of material, can
furthermore contain excipients or additives in order to control the
chemical or physical properties, such as flexibility, mucoadhesive
properties, disintegratability, swellability and/or diffusion properties.
To be taken into consideration as excipients or additives are, in
particular, substances selected from the group consisting of
antioxidants, emulsifiers, gelling agents, flavour enhancers, taste
corrigents, flavours, sweeteners, stabilisers, pH regulators, acidifying
agents, bulking agents, preservatives, colourings, thickening agents,
plasticisers and humectants. Those skilled in the art will know suitable
excipients and additives approved for pharmaceutical applications.

[0074] In one embodiment, the strip has a surface adapted to promote
tissue in-growth. The tissue in-growth promoting surface is desirably
selected from a group of outer surfaces including a textured surface, a
porous surface, a braided surface, a mesh surface, a fleece surface, and
a coating for inducing bone or tissue in-growth.

[0075] One aspect of the present invention is directed to re-shaping the
soft palate in a manner that reduces snoring. Use of the strips of the
present invention can achieve such a feat by building up the structural
integrity of the soft palate in a fashion so that, after time and proper
treatment regimens, the shape of the soft palate is reformed to open up
the airway and reduce snoring noise. Thus the present invention may be
used to re-shape the soft palate for minimizing the likelihood of
obstructive sleep apnea episodes associated with long, flat soft palates
and/or L-shaped soft palates. In one embodiment, when a long, flat soft
palate is causing OSA, an implant having a curved body may be implanted
into the soft palate for increasing the curve of the soft palate. In
another embodiment, when an L-shaped soft palate is causing OSA, an
implant may be inserted for reducing the curve or angle of the soft
palate. Thus, in one embodiment, a plurality of implants having varying
radii may be provided, whereby an implant having a desired amount of
curve may be utilized for increasing or reducing the curve of the soft
palate (i.e. changing the shape of the soft palate). In one embodiment, a
plurality of implants having varying sizes may be provided so as to
enable medical personnel to select an implant having a desired size. In
addition to affecting the soft palate, the strips of the present
invention may further be used in supporting the uvula in a manner that
provides more positive positioning of the uvula and enables the uvula to
provide greater resistance to distal tongue movement, thus providing a
balanced level of uvula support which provides tongue support when
needed, but does not inhibit swallowing. The shape changing feature of
the strips allows greater uvula support (and thereby tongue support)
during times of rest, and less support during waking hours.

[0076] In one embodiment, the strips can comprise collagen or other tissue
growth enhancing material to further the stiffening of the soft palate so
as to reduce the occurrence of vibration when a person is sleeping.
Collagen allows for the tissue in growth (tissue engineering). The
collagen can be in many types and forms, or in combinations thereof. For
example, collagen can be Type I, II or III. Collagen can be native,
denatured or cross linked. The various types and forms of collagen are
described generally in Methods in Enzymol. (1982) 82:3-217, Pt. A, the
contents of which is herein incorporated reference. For example, collagen
can be produced from animal derived tissues such as bovine hides, human
tissues such as cadaver skin or human cell cultures or through
recombinant methods.

[0077] In still other embodiments, the strips are positioned to overlap
with the hard palate as well as the soft palate, thereby modifying the
airflow of a person to reduce snoring. In such embodiments, only a
portion of the soft palate is covered by such a strip as it may not be
necessary to have the entire soft palate encompassed to achieve desired
snoring reduction.

[0078] In other embodiments, the strips may be used to plump up the soft
palate tissue in a manner that makes such tissue more stiff or rigid to a
degree that snoring is reduced due to the reduction in vibrations of such
tissue once plumped. Use of various active agents in contact with and/or
administered via the strips can achieve this plumping of the soft palate
tissue. Slight irritation of the tissue may achieve the similarly desired
stiffening of the tissue and thus, slightly irritating agents can
likewise be utilized. Thus, in a teaching away from prior art references,
use of slightly "toxic" substances may actually be beneficial to achieve
the sought after reduction in tissue vibration of the soft palate. Such
"toxic" substances may also or in addition be simply toxic to bacteria
and other foreign agents.

[0079] The strip surfaces themselves can be modified to achieve desired
airflow characteristics. Thus, channels can be provided to guide airflow
in a manner that reduces snoring noise. The surface of the strip can be
similar to a foam layer such that an insulation layer is provided that
adds support for tissue while also dampening undesired sound or
vibrations during sleep. The height, temperature and construction of
layers on a strip can be adjusted for particular problems encountered in
the wide variety of personal snoring issues. The flexibility of the strip
as a whole or in portions thereof can be modified to address comfort and
support issues. Thus, certain portions of the strip may be more solid to
dampen vibrations, while other portions may be more flexible to
accommodate comfort concerns of a user.

[0080] The present invention provides a non-surgical procedure to
alleviate snoring and thus, is devoid of the pain, incisions, pre- and
post operative requirements and complications, etc. of surgical
procedures used to address snoring problems. The strips are applied in a
temporary rather than permanent manner and thus avoid the complications
one may have when micro-beads are implanted into tissue that may cause
infections, adverse reactions, etc. Nor is the present invention one
where mandible adjustment is required, although it can be used in
association or in parallel with such other non-surgical devices to assist
in achieving a reduction of snoring. The present invention envisions
treatment for snoring only during the sleeping hours of an individual
without having any appliance that would interfere with the cosmetic
nature of one's appearance in bed. For example, a sexual partner in bed
may find it objectionable to a person having to apply a mandibular
adjustment device that may interfere with kissing, romantic encounters,
etc. Obviously, air flow machines would similarly interfere with such
intimate moments. In contrast, the present invention may enhance such
occasions as no outward appliance would be viewable or encountered by a
sexual partner. Moreover, with possible breath freshening components
added to the strip, morning breath and bad breath issues would be
addressed, while the reduction in snoring would itself lead to a happier
bedtime experience for both the wearer and his/her partner.

[0081] A buccal bioadhesive strip, especially one having no active drugs,
when applied to the soft palate, stiffens the tissue to reduce vibration,
and thus snoring sounds, of an individual. The strips preferably have a
surface that is anti-microbial in nature, such that such strips assist in
reducing the surface area in the mouth where noxious odors may arise due
to the proliferation of foul smelling agents produced by bacteria that
can survive in one's mouth.

[0082] Thus, one aspect of the present invention is directed to the novel
combination of a specifically surface structured bioadhesively
attachable, and in a preferred embodiment, dissolvable, strip of material
that persists in the mouth for at least one hour and preferably at least
about 3 hours, so as to stiffen the tissue of the throat, specifically
the soft palate, and thus reduce the occurrence of snoring. The ability
to defeat the proliferation of bacteria in a person's mouth can
significantly decrease the occurrence of so-called "morning breath".

[0083] In one embodiment, a buccal bioadhesive strip having no active
drugs, that when applied to the soft palate, stiffens the tissue to
reduce vibration, and thus snoring sounds, of an individual. The strips
preferably have a surface that is anti-microbial in nature, such that
such strips assist in reducing the surface area in the mouth where
noxious odors may arise due to the proliferation of foul smelling agents
produced by bacteria that can survive in one's mouth.

[0084] Thus, one aspect of the present invention is directed to the novel
combination of a specifically surface structured bioadhesively attachable
and dissolvable strip of material that persists in the mouth for at least
one hour and preferably at least about 3 hours, so as to stiffen the
tissue of the throat, specifically the soft palate, and thus reduce the
occurrence of snoring. The ability to defeat the proliferation of
bacteria in a person's mouth can significantly decrease the occurrence of
so-called "morning breath".

[0085] In various embodiments, the disclosure of various patent
publications owned by Sharklet® (mentioned herein) are incorporated
herein by this reference. Thus, in certain embodiments, a mucosal
adhesive strip has a coated surface for resisting bioadhesion (or in
other aspects, enhancing bioadhesion--so as to further the stiffening
characteristics of the anti-snoring strip) that includes at least one
patterned polymer including coating layer having a plurality of features
attached to or projected into a base surface. The features each have at
least one microscale (<1 mm) dimension and have at least one
neighboring feature having a substantially different geometry. The
patterned coating layer preferably provides an average roughness factor
(R) of from 4 to 50. The coating layer resists or enhances bioadhesion as
compared to the base surface. An article having a surface coating with
topography for controlling bioadhesion comprises a base surface, at least
one patterned polymer comprising coating layer including a plurality of
spaced apart features attached to or projected into the base surface
which provide at least a first feature spacing distance. The features
each have at least one microscale dimension and at least one neighboring
feature having a substantially different geometry. The coating layer
provides an average roughness factor (R) of from 2 to 50, preferably
being from 4 to 50. The coating layer resists or enhances bioadhesion as
compared to the base surface

[0086] Other aspects of the present invention are directed to a method of
preparing an edible water-soluble film composition, said method
comprising: a) preparing a master batch of film-forming components
comprising a water-soluble polymer, a foam reducing flavoring agent
selected from the group consisting of menthol, cherry menthol, cinnamon,
spearmint, peppermint, orange flavor, natural raspberry, and combinations
thereof, and a polar solvent, wherein said foam reducing flavoring agent
is added before mixing said polymer with said solvent; b) mixing said
film-forming components under vacuum; c) wet casting said film-forming
components; and d) removing said polar solvent through a controlled
drying process to form said edible water-soluble film; wherein said film
is free of added defoaming agents. Historically films and the process of
making drug delivery systems therefrom have suffered from a number of
unfavorable characteristics that have not allowed them to be used in
practice. Films that incorporate a pharmaceutically active ingredient are
disclosed in expired U.S. Pat. No. 4,136,145 to Fuchs, et al. ("Fuchs").
These films may be formed into a sheet, dried and then cut into
individual doses. The Fuchs disclosure alleges the fabrication of a
uniform film, which includes the combination of water soluble polymers,
surfactants, flavors, sweeteners, plastickers and drugs. These allegedly
flexible films are disclosed as being useful for oral, topical or enteral
use. Examples of specific uses disclosed by Fuchs include application of
the films to mucosal membrane areas of the body, including the mouth,
rectal, vaginal, nasal and ear areas.

[0087] The formation of agglomerates randomly distributes the film
components and any active present as well. In certain embodiments,
certain portions of the film or strips employed are purposefully not
uniform with respect to the dispersion and location of active
ingredients. Thus, contrary to many prior art teachings, the provision of
a uniform film is not particularly desired in several embodiments. In
fact, films having better adhesive characteristics around the edges, e.g.
where the hard palate is contacted, and less in the soft palate
contacting region of the strip, are preferred for different embodiments.
Like the differences in concentration and presence of active ingredients
in any particular portion of a strip, so too are the physical
characteristics of a strip not necessarily uniform in various
embodiments. Thus, the flexibility and stiffness of certain regions of a
strip may be adjusted to comport with desired objectives, such as
avoidance of tissue irritation, the provision of adhesive to the strips,
inclusion of different drugs, active agents, etc in various amounts,
types and positions in the strip, including different time release agents
that are released at different times during the strip's contact with a
mucosal membrane. The problems of self-aggregation leading to
non-uniformity of a film were addressed in U.S. Pat. No. 4,849,246 to
Schmidt, incorporated herein by this reference. Schmidt specifically
pointed out that the methods disclosed by Fuchs did not provide a uniform
film and recognized that that the creation of a non-uniform film
necessarily prevents accurate dosing, which as discussed above is
especially important in the pharmaceutical area. Other U.S. patents
directly addressed the problems of particle self-aggregation and
non-uniformity inherent in conventional film forming techniques. U.S.
Pat. No. 5,629,003 to Horstmann et al. and U.S. Pat. No. 5,948,430 to
Zerbe et al. incorporated herein by this reference, relate to additional
ingredients, i.e. gel formers and polyhydric alcohols respectively, to
increase the viscosity of the film prior to drying in an effort to reduce
aggregation of the components in the film.

[0088] Conventional drying methods generally include the use of forced hot
air using a drying oven, drying tunnel, and the like. Such methods can be
usefully employed in various embodiments of the present invention, and
thus, in a teaching away from the prior art, such methods can be cost
effectively employed to achieve desired strips having predetermined
characteristics that do not relate to uniformity of dose, thickness, etc.
This makes it far easier to manufacture devices for use and reduces the
costs to the ultimate consumer. Because the films are often very thin, it
can be a challenge to incorporate a high load of active ingredient while
maintaining the film's uniformity. In various embodiments, this is not a
concern, as it is for prior art inventions, as uniformity is not that
imperative to achieve mere structural support for otherwise vibrating
tissue of one's throat.

[0089] Another factor affecting the uniformity of films is the prevention
of air bubbles in the film. Anti-foaming and/or defoaming components may
be used to aid in the removal of air, such as entrapped air, from the
film-forming compositions. Such entrapped air may lead to non-uniform
films. These can be used in certain embodiments of the invention, but
primarily to facilitate other objectives, such as reduction in waste,
etc. One example of a conventional anti-foaming/defoaming component is
simethicone. Simethicone reduces the surface tension of bubbles air
located in the solution, such as foam bubbles, causing their collapse. An
alcohol/water mixture is known to lower water density as well as lower
the water's surface tension. So, any air bubbles trapped inside this
mixture solution will also be dissipated. Simethicone acts as an
anti-foaming/defoaming component by both lowering the surface energy of
any air bubbles trapped inside the aqueous solution, as well as lowering
the surface tension of the aqueous solution. Preferably, a foam reducing
flavoring agent is employed that is present in amount of about 0.1% to
about 20% by weight of the film. In another preferred embodiment, the
foam reducing flavoring agent is present in amount of about 0.5% to about
15% by weight of the film and has a flavoring agent selected from the
group consisting of menthol cherry menthol, cinnamon, spearmint,
peppermint, orange flavor, natural raspberry and combinations thereof. In
another preferred embodiment, the water-soluble polymer includes a
polymer selected from the group consisting of a cellulosic material,
polyethylene oxide, a polysaccharide, a gum, a protein, a starch, a
glucan, and combinations thereof. In another embodiment, the
water-soluble polymer is selected from the group consisting of
carboxymethyl cellulose, hydroxyl methyl cellulose, hydroxyethyl
cellulose, hydroxypropyl cellulose hydroxypropylmethyl cellulose,
polyethylene oxide, and combinations thereof. In another embodiment, the
water-soluble polymer is selected from the group consisting of gum
arabic, xanthan gum, tragacanth, acacia, carageenan, guar gum, locust
bean gum, pectin, alginates and combinations thereof. In another
embodiment, the water-soluble polymer is selected from the group
consisting of polydextrose, dextrin, dextran and combinations thereof.

[0090] The film can also include an active component. In one embodiment,
the active component is selected from the group consisting of cosmetic
agents, pharmaceutical agents, bioactive agents and combinations thereof.
In another embodiment, the active component is present in amounts of up
to about 60% by weight of the film.

[0091] The film can further include one or more agents selected from the
group consisting of taste-masking agents, plasticizing agents,
surfactants, emulsifying agents, thickening agents, binding agents,
cooling agents, saliva-stimulating agents, sweetening agents,
antimicrobial agents and combinations thereof.

[0092] In another aspect of the invention, a method of preparing an
adhesive strip is provided. The method includes: a) preparing a
film-forming composition comprising a water-soluble polymer, a foam
reducing flavoring agent, and a polar solvent; b) mixing said
film-forming composition under vacuum; c) casting said film-forming
composition; and d) removing said polar solvent through a controlled
drying process. Either a foam reducing flavoring agent or a conventional
foam reducing agent can be used, the later preferred as the cost is less
and the avoidance of active ingredients in a structural strip of the
present invention does not necessitate such steps of the prior art.

[0093] Bioadhesion, in particular mucoadhesion, has been of interest for
the development of controlled drug delivery systems to improve buccal and
oral administration of drugs. The oral and nasal cavities, for example,
form convenient and easily accessible sites for drug delivery.
Carboxylated polymers, such as poly(acrylic acid) and crosslinked
poly(acrylic acid), are known to be effective as mucoadhesives
(hereinafter bioadhesive compositions). Various bioadhesive compositions
comprising poly(acrylic acid) are described, e.g., in WO 98/22097; EP
410,696; U.S. Pat. No. 5,643,60; U.S. Pat. No. 4,915,948; U.S. Pat. No.
5,895,804 and U.S. Pat. No. 6,284,235, all of which are incorporated
herein by this reference for particular embodiments of the invention.

[0094] The use of bioadhesive compositions comprising carboxylated
polymers has, however, been limited owing to problems associated with
mucosal irritation. While attempts to reduce the degree of irritation
have included blending these polymers with other materials, including
polysaccharides, efforts to produce non-irritating bioadhesive matrices
have resulted in compositions having decreased bioadhesion, which limits
the amount of drug that can be incorporated into the composition. In
certain embodiments of the present invention, however, because of the
limited time periods where mucosal contact is encountered, the use of
such previously discouraged bioadhesives is suitable for the present
invention. This direction away from what the prior art teaches is part of
the novel characteristics of the present invention. Having said this, in
certain embodiments, use of a bioadhesive composition having increased
bioadhesive properties, decreased irritation, and, in certain
embodiments, the capacity for higher drug loading, is desirable.

[0095] The term "bioadhesive delivery device" as used herein and in the
appended claims means any solid substance, of any shape, which is
intended to be adhered to a mucosal tissue of a subject. The term "buccal
device" or "buccal delivery device" means a bioadhesive device which is
intended to be inserted into the buccal cavity. The term "vaginal device"
or "vaginal delivery device" means a bioadhesive device which is intended
to be inserted into the vagina.

[0096] The term "bioadhesive, closed-cell foam film, sustained release,
delivery device" as used herein and in the appended claims means a
bioadhesive delivery device comprising a closed-cell foam film substance
designed to provide a sustained, controlled release an active agent or
combination of active agents to a subject. These bioadhesive delivery
devices preferably include buccal delivery devices and vaginal delivery
devices.

[0097] The term "controlled release" as used herein and in the appended
claims means that a predetermined dosage of an active agent or
combination of active agents is administered to a subject over a period
of time.

[0098] The term "bioadhesive force" as used herein and in the appended
claims is a quantitative value for tackiness (grams) which simulates the
adhesion of the bioadhesive, closed-cell foam film, sustained release,
delivery devices of the present invention upon contact with a moist
mucosal tissue. The bioadhesive force preferably should be at least 10
grams, more preferably at least 15 grams, most preferably at least 20
grams.

[0099] The term "tensile strength" as used herein and in the appended
claims is expressed in pounds per square inch (psi) and is the property
of a bioadhesive, closed-cell foam film, sustained release, delivery
device of the present invention that requires a load to cause load
deformation failure of said film.

[0100] The term "thickness" as used herein and in the appended claims by
measurements in mil (a mil=one thousandth of an inch) is determined when
a bioadhesive, closed-cell foam film, sustained release, delivery device
of the present invention is placed between two microscopic slides.

[0101] The term "water content" as used herein and in the appended claims
is the % residual water content per unit dose as measured to the Karl
Fisher method and expressed as percent of the dry weight of a
bioadhesive, closed-cell foam film, sustained release, delivery device of
the present invention. Strips that may be used to provide desired
characteristics can be obtained, for example, from: Monosol Rx, LLC
(Portage, Ind.); or Lavipharm Laboratories Inc. (East Windsor, N.J.); and
ARx.

[0102] In certain embodiments, a mucosal adhesive strip has a coated
surface for resisting bioadhesion (or in other aspects, enhancing
bioadhesion--so as to further the stiffening characteristics of the
anti-snoring strip), such strips including at least one patterned polymer
including coating layer having a plurality of features attached to or
projected into a base surface. The features each have at least one
microscale (<1 mm) dimension and have at least one neighboring feature
having a substantially different geometry. The patterned coating layer
preferably provides an average roughness factor (R) of from 4 to 50.
Preferred embodiments include at least one coating layer that either
resists or--alternatively--enhances bioadhesion as compared to the base
surface. Thus, in one embodiment, a buccal bioadhesive strip has no
active drugs and when applied to the soft palate, stiffens the tissue to
reduce vibration, while its surface topography is effective in resisting
bioadhesion. Such a strip comprises at least one coating layer that
comprises a polymer, the coating layer having a pattern defined by a
plurality of spaced apart features attached to or projected into a base
surface, said plurality of features each having at least one microscale
dimension and having at least one neighboring feature having a
substantially different geometry, wherein an average spacing between
adjacent ones of said features is between 0.5 and 5 μm in at least a
portion of the coating layer, the coating layer resisting bioadhesion as
compared to said base surface. U.S. Pat. No. 7,143,709 is incorporated
herein by this reference.

[0103] A strip of the present invention in various embodiments comprises a
surface having a topography for controlling bioadhesion comprises a base
surface, at least one patterned polymer comprising coating layer
including a plurality of spaced apart features attached to or projected
into the base surface which provide at least a first feature spacing
distance. In certain embodiments, such topography has features that each
have at least one microscale dimension and at least one neighboring
feature having a substantially different geometry. Preferably, the strips
have a surface layer imported to them that provides an average roughness
factor (R) of from 2 to 50, preferably being from 4 to 50, and most
preferably has an R factor of about 30.

[0104] In various embodiments, the present invention is distinguished from
the prior art in one of several ways, including:

[0105] certain embodiments entail the use of a specially textured surface,
either one both or at least the outer side of an adhesive strip (the side
facing away from the mucosal tissue to which it is attached) that has
anti-microbial characteristics. In one such embodiment, the surface
topography is such that it resists bioadhesion of undesired bacteria that
are typically present in a human's mouth. Such a surface may comprise a
layer or coating that comprises a pattern defined by a plurality of
spaced apart features attached to or projected into a base surface, with
a plurality of features each having at least one microscale dimension and
having at least one neighboring feature having a substantially different
geometry, and having an average spacing between adjacent ones of said
features of between 0.5 and 5 μm. Incorporated herein by this
reference is U.S. Pat. No. 7,650,848 to address written description and
enablement issues regarding the use of suitable textures and surfaces
that may be employed. Thus, preferred embodiments include strips that
have a surface upon which bacteria do not like to grow, in particular,
surfaces having a surface texture and/or pattern that faces away from the
mucosal contacting side of the strip and that reduces the number of
bacteria that would normally occupy such surface area of the mucosal
membrane where the patch/strip no adhered thereto. creates a surface upon
which bacteria do not like to grow. Exemplary surfaces that can be
employed for such purpose include those in FIG. 2(a-d)

[0106] Certain embodiments of the patch have overall geometries
particularly suited for the individual's mouth and are customizable
therefore. As such, perforated tear lines such that smaller sizes can be
fashioned easily. Other geometries of strips are such that they limit
common "gag reflexes" of a person, while still achieving the objective of
reducing the vibrational flutter of tissue that causes snoring.
Particular strips are designed so as to also extend over not only a
majority of the soft palate region, but also over the hard palate, so as
to father reduce the incidence of gag reflexes being triggered; [0107]
certain embodiments have toxic substances associated with the surface of
the strips, thereby killing certain undesired bacteria in the mouth;
[0108] certain embodiments comprise bioluminescent strips to facilitate a
user's ability to view (in a mirror) the correct placement of the strips
in one's throat. Bioluminescence is a type of chemiluminescence and in
certain embodiments, a catalytic protein increases the efficiency of
chemiluminescent reaction such that a bioluminescent protein is
determined by detecting the presence of luminescence. Bioluminescent
compounds that may be employed in the present invention embodiments
include luciferin, luciferase and aequorin. Other embodiments employ
differences in visual appearance to determine whether a patch is placed
properly; whether certain desired or undesired bacteria are present in
the mouth, etc, and such effective means for determining the same include
a film, coating or patch that includes one or more of the following
characteristics: reflectance, retroreflectance, fluorescence,
photoluminescent light transmission, color, tinting strength, and
whiteness. In one particular embodiment, in addition to addressing
snoring issues, certain embodiments may also assist in the detection of
whether a person has a certain medical condition, such as strep throat.
Thus, in one embodiment, the patch changes color, expresses
bioluminescence, etc. if there is strep bacteria present in a
predetermined amount. Incorporated herein by this reference for written
description purposes is U.S. Pat. Publication No. 20110250626 to
Williams, et al. [0109] certain embodiments employ a non-fast drying
adhesive to eliminate the discomfort sometimes associated with fast
drying adhesives;

[0111] certain embodiments have compounds residing thereon to facilitate
the growth of desired bacteria, such as those deemed beneficial or at
least not detrimental to a person's health, and in some circumstances,
that build up in a manner that further promotes the reduction of
vibration of the underlying tissue; [0112] certain embodiments include
the use of phase change materials such that when certain temperatures are
encountered while in use, the phase change occurs, thus resulting in
physical characteristics of the overall strip to be modified so as to,
for example, increase the stiffness of the strip, reducing vibration of
the underlying tissue, etc. Incorporated herein by this reference for the
purpose of understanding the various characteristics and selection of
appropriate phase change materials are the following: U.S. Pat. Nos.
7,666,502; and 7,579,078. [0113] certain embodiments employ materials
that cause the strip to stiffen when exposed to either vibration (such as
that encountered during the snoring of an individual) or upon slight
changes in temperature, such as caused by a person mouth snoring. In such
a manner, when the strip experiences air flow that cools the materials,
such as phase change material, it causes a stiffening of the strip, thus
reducing the vibration of the underlying tissue to which the strip is
adhered to; [0114] certain embodiments include the provision of
structural features that direct airflow in a manner that further reduces
the occasion of throats tissue vibration. As such, for example,
particular grooves, hollow structures and curved surfaces can be employed
to address the particular air-flow patterns within a person's throat so
as to reduce the occurrence of snoring. In one embodiment, heat reactive
materials are included in the strip to effect a desired change or
modification of stiffness of the strip under certain environmental
conditions. For example, the strip is provided with a sufficient amount
of heat change materials that when exposed to the increased air cooling
effects caused by a person's snoring, act to stiffen the strip so as to
add to the anti-vibrational characteristics of the strip when in contact
with the soft palate of the individual snoring. When the passage of air
over the soft palate is such that the temperature of the environment
around the strip is warmer, the heat change materials react in a manner
that lessens the rigidity of the overall strip. Various materials can be
employed in various embodiments of the invention to achieve such desired
results. For example, a suitable polymorph, such as polycaprolactone, a
biodegradable polyester with a low melting point of around 60° C.
(140° F.), can be used as one of several agents to achieve a
desired flexibility of a strip.

[0115] Similarly, Shape Memory Polymers (SMP) can be re-shaped when
exposed to heat and will retain this new shape after cooling down. SMPs
can retain two or sometimes three shapes, and the transition between
those is induced by temperature. In addition to temperature change, the
shape change of SMPs can also be triggered by an electric or magnetic
field, light or solution. As well as polymers in general, SMPs also cover
a wide property-range from stable to biodegradable, from soft to hard,
and from elastic to rigid, depending on the structural units that
constitute the SMP. SMPs include thermoplastic and thermoset (covalently
cross-linked) polymeric materials.

[0116] Heat-Shrink materials can also be used, such as those manufactured
from a thermoplastic (such as nylon or polyolefin) which shrinks when
exposed to heat. In certain embodiments, the material used contains many
monomers that when heated, polymerise, increasing the density of the
material as the monomers become bonded together and the volume of the
material shrinks Conversely, other heat shrink materials are
expansion-based, where heating to just above the polymer's crystalline
melting point permits the material to become less rigid and later cooling
acts to relax. A mixture of such materials can be done to achieve desired
overall characteristics of any particular strip for use for the present
invention purposes.

[0117] Suitable environmentally changeable strips can, in addition to
reliance on heat variance to modify physical rigidity characteristics,
also have their rigidity modified via the degree of moisture absorbed by
the strip. For example, when snoring, the air drying aspects of the
throat causes the strip to lose moisture, and thus, increase in rigidity,
thus causing a consequential stiffening of the underlying tissue to which
the strip is adhesively attached. When snoring ceases, the air flow is
reduced, lessening the moisture loss from the strip, and causing the
strip to regain flexibility and become less rigid. Preferably, the
materials used have a curing temperature suitable for body heat
transitions experienced during a snoring episode, and thus heat-curable
polymer particles have a curing temperature of about 96 degrees F.
Incorporated herein by this reference is U.S. Pat. Pub. No. 20060188813
to Shimada for various materials that can be employed for the same,
albeit modified to attain the desired temperature curing abilities for
the purposes set forth herein. Edible prolamine and other edible coatings
are preferred as they are non-toxic because they are formed from a
naturally-occurring, common food protein, and can thus be used as they do
not contain organic solvents or require extreme pH's.

BRIEF DESCRIPTION OF THE FIGURES

[0118] FIG. 1 is a cross-sectional view of a person's airway where a
particular placement of a snore strip is shown associated with the soft
palate.

[0119]FIG. 2(a)-(d) illustrate some exemplary surface architectural
patterns according to the invention.

[0120]FIG. 3 is a front perspective view of a person's open mouth,
illustrating the placement of a snore strip on the surface of the soft
palate.

[0121]FIG. 4A is an illustration of a person's mouth with a heart-shaped
snore strip associated with the soft palate and a teeth anchor associated
with such snore strip.

[0122]FIG. 4B is an illustration of a person's mouth with a rectangular
shaped snore strip adhered to the soft palate with mucosal adhesive
agents.

[0123]FIG. 5 is an illustration of a person's open mouth with a snore
strip place on the soft palate and a dental floss attachment anchor
associated between the strip and a the teeth.

[0124]FIG. 6A is an illustration of a person's open mouth where a first
rectangular snore strip is over-laid by a 2nd circular snore strip.

[0126]FIG. 7 illustrates a snore strip having a cross-hatched support
structure integral with the strip to provide desired damping of
vibrational movement of the soft palate.

[0127]FIG. 8 is a cross-sectional view of a person's head where a snore
strip is anchored by a tongue loop anchor.

[0128]FIG. 9 illustrates a strip applicator for placing a snore strip
properly on the soft palate.

[0129] The foregoing describes numerous embodiments of an invention for an
implant for the soft palate to alter a dynamic response of the soft
palate. The invention is much less traumatic than prior surgical
treatments. Further, the invention permits use of reversible procedures
as well as procedures which can be selectively tuned both during surgery
and post-operatively. Having described the invention, alternatives and
embodiments may occur to one of skill in the art.